/>iIn an opinion letter dated November 8, 2024, the Wage and Hour Division of the U.S. Department of Labor (DOL) responded to a question posed by an organization dedicated to finding a cure for specific diseases. At issue was the question of whether treatment provided as part of a clinical trial would meet the definition of “treatment” as broadly defined under the Family and Medical Leave Act (FMLA).
In providing its opinion, the DOL noted, “When all other FMLA eligibility requirements are met, a serious health condition that involves either inpatient care or continuing treatment by a health care provider, including when such care or treatment involves an individual’s voluntary participation in a clinical trial, qualifies the employee to use FMLA leave.”
Quick Hits
- The DOL’s Wage and Hour Division clarified that participation in a clinical trial can qualify as “treatment” under the FMLA if it involves an employee’s own serious health condition and all other FMLA eligibility requirements are met.
- The Wage and Hour Division, acknowledging the experimental nature of some clinical trials, emphasized that the FMLA regulations’ definition of “continuing treatment” does not require that a clinical trial meet a certain level of efficacy or achieve specific results.
It is important to note that the opinion was responsive to a narrative in which the facts surrounded an individual’s ability to take leave under the FMLA to participate in a clinical trial addressing the individual’s own serious health condition. This leaves the door open to a question of whether the opinion would vary if the requested leave related to a clinical trial not involving an employee’s own serious health condition—for instance, as a healthy volunteer.
The DOL explored the concept of clinical trials at times being “experimental” and decisively noted that “the regulatory definition [of “continuing treatment”] does not contain any requirement that the treatment meet a certain level of efficacy or that it achieves a certain result.”
All opinion letters issued by the DOL are fact-specific to the individual circumstances presented to the department. However, this opinion letter may cause employers to, minimally, give significant consideration to FMLA requests by employees to participate in clinical trials. If a clinical trial is designed to treat an individual’s own serious health condition, the employer may want to consider approval of such a request, assuming all other elements of FMLA eligibility are met.
